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510(k) K061559

Device
ACON URINALYSIS REAGENT STRIPS
Applicant
ACON LABORATORIES CO.
510(k) number
K061559
Product code
CDM  
Decision
Substantially Equivalent (SESE)
Decision date
2006-08-11
Date received
2006-06-05
Regulation
862.1785
Classification name
Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARTIN O'CONNOR
Address
4139 Gardendale Center # 101 San Antonio TX US 78229 78229

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CDM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K052719URITEST 10 URINALYSIS REAGENT STRIPSArj Medical, Inc.2006-12-05
K880584URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8CMach Diag. C/O Wichita State University1988-05-31
K873366WAKO(TM) PRETEST 5AWako Chemicals USA, Inc.1988-01-21
K852611TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINEMiles Laboratories, Inc.1985-09-03
K821799FITKIT I CHECKUP KITPatton, Boggs & Blow1983-08-16
K830340FITKIT I CHECKUP KITBoditestor1983-08-16
K831623DIA STRIPS SYSTEMCalifornia Immuno Diagnostic, Inc.1983-07-28
K790965REAGENT STRIPS FOR URINALYSISMiles Laboratories, Inc.1979-06-28

Legacy Summary#

summary

FDA Review#

Decision Summary